FDA Device · 2017

FDA Device recalls in 2017

RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.

• DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat…
  FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
• Dimension Vista Estradiol (E2) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat rec…
  FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
• MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752
  FDA Device · Class II · 2017-06-28 · Medtronic
• Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• Dimension Vista Prolactin (PRL) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• Dimension Vista Ferritin (FERR) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare…
  FDA Device · Class II · 2017-06-28 · Omega Medical Imaging
• DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to t…
  FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
• MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760
  FDA Device · Class II · 2017-06-28 · Medtronic
• DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurr…
  FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
• Merge OrthoPACS software
  FDA Device · Class II · 2017-06-28 · Merge Healthcare
• Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• Venture RX Catheter, Model 5820
  FDA Device · Class I · 2017-06-28 · Vascular Solutions
• ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination o…
  FDA Device · Class II · 2017-06-28 · Abbott Laboratories
• Proteus 235
  FDA Device · Class II · 2017-06-28 · Ion Beam Applications
• MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750
  FDA Device · Class II · 2017-06-28 · Medtronic
• Dimension Troponin 1 (TNI) Flex reagent cartridge
  FDA Device · Class II · 2017-06-28 · Siemens Healthcare Diagnostics
• MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755
  FDA Device · Class II · 2017-06-28 · Medtronic
• QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield…
  FDA Device · Class II · 2017-06-28 · Z Medica
• DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat…
  FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
• VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare Optima CT580
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare Discovery NM/CT 570c X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P650), IVD, REF 421296, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N213), REF 413063, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr…
  FDA Device · Class II · 2017-06-21 · Arrow International
• VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Pereyra-Raz Ligature Carrier
  FDA Device · Class II · 2017-06-21 · Cook
• VITEK¿ 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N208), IVD, REF 413062, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Sutures
  FDA Device · Class II · 2017-06-21 · Medtronic
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN73), REF 413404, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central c…
  FDA Device · Class II · 2017-06-21 · Arrow International
• Por fullct fem st 16x200mm, Sterile
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N243), REF 413392, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare Optima CT520 X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N232), REF 413116, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Video Bronchoscope
  FDA Device · Class II · 2017-06-21 · Pentax
• Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare BrightSpeed X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N236), REF 413171, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Merge PACS software
  FDA Device · Class II · 2017-06-21 · Merge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare Optima CT540 X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access an…
  FDA Device · Class II · 2017-06-21 · Arrow International
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
  FDA Device · Class II · 2017-06-21 · Creganna Medical Devices
• GE Healthcare Revolution EVO X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas…
  FDA Device · Class II · 2017-06-21 · Cook
• Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
  FDA Device · Class II · 2017-06-21 · Creganna Medical Devices
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux

Other years

2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)